Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent

Hepatocellular Carcinoma Clinical Trial

Official title: A Multicenter, Open-label, Dose Escalation and Expansion, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PB101 in Patients With Advanced Solid Tumor

Status Recruiting

Clinical Trial Summary

This clinical trial is designed as a multi-center, open-label, dose-escalation, dose-expansion, phase 1 clinical trial and will be evaluating the safety and efficacy of PB101 in patients with advanced solid tumors who have progressed after standard of care.

PB101 may stop the growth of tumor cells by blocking blood flow to the tumor and modulating the tumor microenvironment.

Clinical Trial Description

Primary Objectives

To assess the safety and tolerability of PB101 and determine the maximum tolerated dose (MTD) and/or the recommended phase-2 dose

Secondary Objectives

1. To characterize the pharmacokinetics of PB101.

2. To identify the preliminary anti-tumor activity of PB101.

3. To assess the immunogenicity of PB101.

Tertiary Objectives

To explore the correlation between potential pharmacodynamic (PD) biomarkers (e.g., vascular endothelial growth factor(VEGF)-A, placental growth factor (PlGF) and VEGFR1 signaling) and anti-cancer activity of PB101. ;

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Gastric Cancer
• Hepatocellular Carcinoma
• Metastatic Colorectal Cancer
• Neoplasms
• Solid Tumor
• Solid Tumor, Adult

• NCT number: NCT06075849
• Study type: Interventional
• Source: Panolos Bioscience
• Contact: Jin A Shin, PhD
• Phone: +82)31-8055-0886
• Email: jashin@panolos.com
• Status: Recruiting
• Phase: Phase 1
• Start date: October 25, 2023
• Completion date: January 2025